Future looks very clear for Novartis psoriasis drug

A week or so ahead of a US advisory committee, Novartis has presented more impressive data for its closely-watched psoriasis drug secukinumab.

New analyses of Phase III studies have been presented at the European Association of Dermatology and Venereology congress in Amsterdam which show that treatment with secukinumab 300mg resulted in higher rates of clear to almost clear skin at week 12 versus placebo, regardless of patients' psoriasis disease severity.

The majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin (100% or 90% reduction by the PASI index). Importantly, Novartis noted, skin clearance was sustained through one year of treatment.

The Swiss major was also excited about an analysis which showed that significantly more patients on secukinumab, experienced clear or almost clear skin with no quality of life impairment. Speaking to journalists at EADV, Peter van der Kerkhof of Radboud University Nijmegen Medical Centre, said that effect on patients' quality of life is similar to cancer, heart disease, arthritis, type 2 diabetes and depression, noting that the psychological effect as well as the physical symptoms affect psoriasis patients enormously.

He told PharmaTimes that the side effect profile for secukinumab, which targets the interleukin-17A protein, is excellent, adding that malignancy signals were zero in trials. He added that the data of these analyses, and previous studies showing superiority to Amgen’s Enbrel (etanercept), an anti-TNF standard of care, show that scores of PASI 90 and above “are not just imagination, they are reality”.

It all augurs well for secukinumab which will be reviewed by a US Food and Drug Administration advisory committee meeting on October 20 and Novartis expects a recommendation from advisors to the European Medicines Agency in 2015. The company has also recruited nearly 700 patients for a head-to-head study versus Johnson & Johnson’s already-approved Stelara (ustekinumab)

Secukinumab is also in trials for ankylosing spondylitis and rheumatoid arthritis, and it is about to be filed for psoriatic arthritis.